For the first time, people with the skin discoloration disorder vitiligo will have a topical treatment.
The U.S. Food and Drug Administration granted approval on Monday for Opzelura, which is the first topical JAK inhibitor cream for the treatment of vitiligo for people 12 and older.
This is great news for the estimated 1.9 million to 2.8 million adults in the U.S. that are living with the incurable and difficult-to-control autoimmune disorder, which is caused by antibodies that attack a person’s pigment-producing cells causing patches of skin to lose color and become almost chalk white. On Black skin/darker skin tones vitiligo is more noticeable.
Treatment for those with unmet medical needs
“There’s a large unmet medical need here in vitiligo,” Dr. Steven Stein, Chief Medical Officer at Incyte, told ABC News. “This opens a completely new door, new avenue for them and for patients who want therapy to repigment.”
“With the approval of Opzelura in nonsegmental vitiligo, Incyte has once again delivered a treatment to patients with high unmet medical need who previously had no approved therapies,” Hervé Hoppenot, Incyte’s chief executive officer, said in a press release.”We are proud of Incyte’s scientists and development teams that have made this milestone possible, and we’re pleased that eligible vitiligo patients now have a choice to address repigmentation.”
While the discoloration caused by vitiligo doesn’t typically cause medical risks, it can result in physical complications, including eye issues, hearing problems and severe sunburn. People with vitiligo also often have to face harsh reactions and judgment from others.
Another benefit of this new treatment is that it will provide vitiligo patients with something more long-term. Prior to this treatment, oral and topical steroids were a common treatment for vitiligo, however, they weren’t a long-term solution for the condition.
“Since long-term use of steroids has a lot of side effects, dermatologists are always looking for steroid-sparing agents.” Dr. Mansha Sethi, a board-certified dermatologist in Houston, who was not involved in the clinical trial, told ABC News.
Another treatment doctors use to treat vitiligo is phototherapy. Phototherapy works by stimulating cells to make skin pigment. The downside to this option is that it isn’t always easy to implement because it can be expensive and involves going into an office equipped with phototherapy devices multiple times a week, every week.
Now with FDA approval, many people will have access to a treatment that will be